Peest D, Deicher H, Coldewey R, Leo R, Bartl R, Bartels H, Braun H J, Fett W, Fischer J T, Göbel B
Abt. Immunologie und Transfusionsmedizin, Zentrum Innere Medizin und Dermatologie, Medizinische Hochschule Hannover, Germany.
Eur J Cancer. 1995;31A(2):146-51. doi: 10.1016/0959-8049(94)00452-b.
406 untreated multiple myeloma patients of stage I (n = 54), II (n = 148) and III (n = 204) were enrolled in the trial. 51/54 stage I and 60/148 stage II patients were asymptomatic and followed without treatment until disease progression (progression free survival: 60% after 4 years for stage I versus 50% after 1 year for stage II). Symptomatic patients of stage I (n = 3/54) and II (n = 88/148) presenting with tumour progression, received melphalan 15 mg/m2 intravenously (i.v.) and prednisone 60 mg/m2 oral days 1-4 (MP). Stage II disease remission rate was 59%, and 50% tumour related survival (TRS) was 59 months. Stage III patients were randomised to receive MP or VBAMDex (vincristine/BCNU/doxorubicin/melphalan/dexamethasone) treatment. 43% of MP treated patients responded compared with 64% of the VBAMDex group. 50% TRS was 36 months in both groups without a detectable difference. 117 responders of stage II and III with stable disease were randomised to receive either IFN-alpha (5 x 10(6) IU, subcutaneous (S.C.) 3 times per week) or no maintenance treatment. The relapse rate in both groups was 50% after 13 months. No survival benefit for IFN alpha treated patients was observed (50% TRS: 45 months).
406例未经治疗的I期（n = 54）、II期（n = 148）和III期（n = 204）多发性骨髓瘤患者入组该试验。51/54例I期和60/148例II期患者无症状，在不进行治疗的情况下随访直至疾病进展（无进展生存期：I期4年后为60%，II期1年后为50%）。I期（n = 3/54）和II期（n = 88/148）出现肿瘤进展的有症状患者，接受美法仑15mg/m²静脉注射（i.v.）和泼尼松60mg/m²口服第1 - 4天（MP）。II期疾病缓解率为59%，50%的肿瘤相关生存期（TRS）为59个月。III期患者被随机分配接受MP或VBAMDex（长春新碱/卡氮芥/阿霉素/美法仑/地塞米松）治疗。接受MP治疗的患者中有43%有反应，而VBAMDex组为64%。两组的50% TRS均为36个月，无明显差异。117例II期和III期病情稳定的缓解患者被随机分配接受干扰素-α（5×10⁶IU，皮下注射（S.C.），每周3次）或不进行维持治疗。两组13个月后的复发率均为50%。未观察到干扰素-α治疗患者的生存获益（50% TRS：45个月）。
